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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD LINEAR 7.5 FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD LINEAR 7.5 FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0475
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/16/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Device evaluation: the failure was confirmed by a company representative during the testing. The device was evaluated and it was determined that the membrane was wrapped incorrectly by the operator during the tight wrapping operation. This is evident by the folds present in the membrane after it was pulled from retainer, see. When comparing the improperly folded membrane in, to a properly folded membrane also tested in this protocol it is clear that the membrane was wrapped incorrectly. An additional comparison can also be made between the improperly folded membrane and the non-acceptable sample pictures from the linear 7. 5fr. Iab tight wrap packaging & inspection procedure. (b)(4).
 
Event Description
It was reported by a datascope representative that an iab was found to have a failure for pull from retainer force after it had been released for distribution, during testing for a protocol. The value was 5. 04lb which exceeds the <5lb requirement.
 
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Brand NameLINEAR 7.5 FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
15 law drive
fairfield, NJ 07004
MDR Report Key7859433
MDR Text Key119811232
Report Number2248146-2018-00537
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/02/2019
Device Catalogue Number0684-00-0475
Device Lot Number3000039567
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received08/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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